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The classification systems provided by Regulation (EU) 2017/745 (Article 51 and Annex VIII) and Regulation (EU) 2017/746 (Article 47 and Annex VIII) can be used for this. The classifications use a ‘risk based’ system based on the vulnerability of the human body taking account of the potential risks associated with the devices.
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Source: EUR-Lex (Cellar) · retrieved 2026-09-07 · Text as adopted (Official Journal); later amendments are not incorporated in this text.